Out-of-specifi cation results or signifi cant atypical trends should be investigated.
Any confi rmed signifi cant change, out-of-specifi cation result, or signifi cant
atypical trend should be reported immediately to the relevant fi nished product
manufacturer. The possible impact on batches on the market should be
considered in consultation with the relevant fi nished product manufacturers
and the competent authorities.
A summary of all the data generated, including any interim conclusions on
the programme, should be written and maintained. This summary should be
subjected to periodic review.